(83 days)
Acupuncture needles are defined as devices intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
The subject of this 510(k) application - the TAKI acupuncture needle - is a sterile, single use only acupuncture needle. The TAKI acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture.
This 510(k) summary describes a pre-market notification for the TAKI acupuncture needle. However, it does not contain the level of detail typically found in a study proving a device meets specific acceptance criteria in the way a diagnostic AI algorithm study would. The document focuses on regulatory equivalence rather than a detailed performance study with quantitative metrics.
Therefore, I cannot provide a table of acceptance criteria vs. reported device performance, nor can I answer questions related to sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the information provided for this device.
Here's what I can extract based on the provided text, heavily reinterpreting the "acceptance criteria" through a regulatory lens:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Interpreted from 510(k)) | Reported Device Performance (TAKI Acupuncture Needle) |
|---|---|
| Safety: | |
| No serious or life-threatening accidents | "no accidents or device failure claims have been reported as a result of using the TAKI brand acupuncture needle [since 1988]." |
| Sterile for single use | "is a sterile, single use only acupuncture needle." |
| Effectiveness/Functionality: | |
| Meets general specifications & criteria for an acupuncture needle | "The TAKI acupuncture needle meets the general specifications and criteria for an acupuncture needle and is effective for the practice of acupuncture." |
| Effective for the practice of acupuncture | "effective for the practice of acupuncture." |
| Equivalence: | |
| Equivalent to pre-amendment devices (prior to May 28, 1976) | "The TAKI needle is equivalent to acupuncture needles which were in commercial distribution prior to May 28, 1976." |
| Equivalent to currently marketed devices | "the TAKI needle is equivalent to other acupuncture needles which are currently being sold through interstate commerce." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document does not describe a test set or a study with quantitative performance metrics. The "performance" is based on the general lack of adverse events during real-world use and meeting general specifications.
- Data Provenance: The statement regarding no reported accidents or device failures since 1988 indicates historical, real-world usage data. The country of origin for this data is not specified, but the device was "imported and sold through interstate commerce in the USA since 1988," suggesting the absence of reports pertains to US usage. This would be considered retrospective observational data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "test set" in the sense of a collection of cases requiring expert ground truth for performance evaluation of a diagnostic algorithm. The "ground truth" for this device is effectively its general acceptance, safety record, and functional equivalence.
4. Adjudication method for the test set
- Not applicable, as there was no test set or expert ground truthing process described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not a diagnostic AI device, and therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used
- The "ground truth" for this regulatory submission is based on several factors:
- Historical Safety Record: The absence of reported adverse events over years of commercial distribution in the US.
- General Acceptance/Longstanding Use: The statement that "Acupuncture needles have been used for the general practice of acupuncture in the United States for over 30 years" and that pre-amendment devices were non-sterile highlights the historical context and general understanding of acceptable performance for this device type.
- Compliance with General Specifications: The device "meets the general specifications and criteria for an acupuncture needle." This implies adherence to established industry or regulatory standards for such devices, although specific standards are not listed.
- Equivalence to Predicate Devices: The core of a 510(k) relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing a completely new "ground truth" for performance.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
§ 880.5580 Acupuncture needle.
(a)
Identification. An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.(b)
Classification. Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109,
(2) Device material biocompatibility, and
(3) Device sterility.